Generated Narrative: StructureDefinition Group-uv-epi

Name Flags Card. Type Description & Constraints doco
. . Group 0 .. * Group Group of multiple entities
. . . type 1 .. 1 code person | animal | practitioner | device | careteam | healthcareservice | location | organization | relatedperson | specimen
Required Pattern: person
. . . membership 1 .. 1 code definitional - the group is defined by the characteristics below, not by an enumerated member list
Required Pattern: definitional
. . . Slices for characteristic 1 .. * BackboneElement One population axis. Combine multiple characteristics with AND. Open: add further axes as needed.
Slice: Unordered, Open by pattern:code
. . . . characteristic:sex 0..1 BackboneElement Include / Exclude group members by Trait
. . . . . code 1 .. 1 CodeableConcept Kind of characteristic
Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: sex
. . . . . value[x] 1 .. 1 CodeableConcept Value held by characteristic
Binding: Group Sex Value (ePI) ( extensible )
. . . . characteristic:age 0..1 BackboneElement Age range. Use UCUM 'a' (years) or 'd' (days) so neonatal/paediatric bands can be expressed.
. . . . . code 1 .. 1 CodeableConcept Kind of characteristic
Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: age
. . . . . value[x] 1 .. 1 Range Value held by characteristic
. . . . characteristic:bodyWeight 0..1 BackboneElement Body weight as a population selector (e.g., ≥ 40 kg). Distinct from mg/kg dose rates, which are expressed in Dosage.doseAndRate.
. . . . . code 1 .. 1 CodeableConcept Kind of characteristic
Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: body-weight
. . . . . value[x] 1 .. 1 Range Value held by characteristic
. . . . characteristic:race 0..* BackboneElement Include / Exclude group members by Trait
. . . . . code 1 .. 1 CodeableConcept Kind of characteristic
Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: race
. . . . . value[x] 1 .. 1 CodeableConcept Value held by characteristic
Binding: Group Race Value (ePI) ( extensible )
. . . . characteristic:lifestyle 0..* BackboneElement Include / Exclude group members by Trait
. . . . . code 1 .. 1 CodeableConcept Kind of characteristic
Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: lifestyle
. . . . . value[x] 1 .. 1 CodeableConcept Value held by characteristic
Binding: Group Lifestyle Value (ePI) ( extensible )
. . . . characteristic:renalFunction 0..1 BackboneElement Renal function, typically a creatinine-clearance range in mL/min.
. . . . . code 1 .. 1 CodeableConcept Kind of characteristic
Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: renal-function
. . . . . value[x] 1 .. 1 Range Value held by characteristic
. . . . characteristic:hepaticFunction 0..1 BackboneElement Include / Exclude group members by Trait
. . . . . code 1 .. 1 CodeableConcept Kind of characteristic
Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: hepatic-function
. . . . . value[x] 1 .. 1 CodeableConcept Value held by characteristic
Binding: Group Hepatic Function Value (ePI) ( extensible )
. . . . characteristic:immuneStatus 0..* BackboneElement Include / Exclude group members by Trait
. . . . . code 1 .. 1 CodeableConcept Kind of characteristic
Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: immune-status
. . . . . value[x] 1 .. 1 CodeableConcept Value held by characteristic
Binding: Group Immune Status Value (ePI) ( extensible )

doco Documentation for this format
<status value="active" /> <experimental value="true" /> <date value="2026-07-01T13:09:50+00:00" /> <publisher value="HL7 International / Biomedical Research and Regulation" /> <contact> <name value="HL7 International / Biomedical Research and Regulation" /> <telecom> <system value="url" /> <value value="http://hl7.org/Special/committees/rcrim" /> </telecom> </contact> <description value="Group (ePI) - a definitional population used to stratify clinical use and dosing. A Group is the single, canonical representation of a population in an ePI. It is referenced from: * ClinicalUseDefinition.population - the population an indication / contraindication / interaction / undesirable effect / warning applies to, and * (conceptually) the population a structured dose is intended for. Each population axis (sex, age, weight, race, lifestyle, renal/hepatic function, immune status) is one `characteristic`. Multiple characteristics are combined with AND. The slicing is **open**: real product information regularly stratifies on axes not enumerated here, and authors may add further characteristics." /> <jurisdiction> <coding> <system value="http://unstats.un.org/unsd/methods/m49/m49.htm" /> <code value="001" /> <display value="World" /> </coding> </jurisdiction> <fhirVersion value="5.0.0" /> <mapping> <identity value="w5" /> <uri value="http://hl7.org/fhir/fivews" /> <name value="FiveWs Pattern Mapping" /> </mapping> <mapping> <identity value="rim" /> <uri value="http://hl7.org/v3" /> <name value="RIM Mapping" /> </mapping> <mapping> <identity value="interface" /> <uri value="http://hl7.org/fhir/interface" /> <name value="Interface Pattern" /> </mapping> <kind value="resource" /> <abstract value="false" /> <type value="Group" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Group" /> <derivation value="constraint" /> <snapshot> <extension url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version"> <valueString value="5.0.0" /> </extension> </snapshot> <differential> <element id="Group"> <path value="Group" /> </element> <element id="Group.type"> <path value="Group.type" /> <patternCode value="person" /> </element> <element id="Group.membership"> <path value="Group.membership" /> <short value="definitional - the group is defined by the characteristics below, not by an enumerated member list" /> <patternCode value="definitional" /> </element> <element id="Group.characteristic"> <path value="Group.characteristic" /> <slicing> <discriminator> <type value="pattern" /> <path value="code" /> </discriminator> <rules value="open" /> </slicing> <short value="One population axis. Combine multiple characteristics with AND. Open: add further axes as needed." /> <min value="1" /> </element> <element id="Group.characteristic:sex"> <path value="Group.characteristic" /> <sliceName value="sex" /> <min value="0" /> <max value="1" /> </element> <element id="Group.characteristic:sex.code"> <path value="Group.characteristic.code" /> <patternCodeableConcept> <coding> <system value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type" /> <code value="sex" /> </coding> </patternCodeableConcept> </element> <element id="Group.characteristic:sex.value[x]"> <path value="Group.characteristic.value[x]" /> <type> <code value="CodeableConcept" /> </type> <binding> <strength value="extensible" /> <valueSet value="http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/group-sex-value" /> </binding> </element> <element id="Group.characteristic:age"> <path value="Group.characteristic" /> <sliceName value="age" /> <short value="Age range. Use UCUM 'a' (years) or 'd' (days) so neonatal/paediatric bands can be expressed." /> <min value="0" /> <max value="1" /> </element> <element id="Group.characteristic:age.code"> <path value="Group.characteristic.code" /> <patternCodeableConcept> <coding> <system value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type" /> <code value="age" /> </coding> </patternCodeableConcept> </element> <element id="Group.characteristic:age.value[x]"> <path value="Group.characteristic.value[x]" /> <type> <code value="Range" /> </type> </element> <element id="Group.characteristic:bodyWeight"> <path value="Group.characteristic" /> <sliceName value="bodyWeight" /> <short value="Body weight as a population selector (e.g., ≥ 40 kg). Distinct from mg/kg dose rates, which are expressed in Dosage.doseAndRate." /> <min value="0" /> <max value="1" /> </element> <element id="Group.characteristic:bodyWeight.code"> <path value="Group.characteristic.code" /> <patternCodeableConcept> <coding> <system value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type" /> <code value="body-weight" /> </coding> </patternCodeableConcept> </element> <element id="Group.characteristic:bodyWeight.value[x]"> <path value="Group.characteristic.value[x]" /> <type> <code value="Range" /> </type> </element> <element id="Group.characteristic:race"> <path value="Group.characteristic" /> <sliceName value="race" /> <min value="0" /> <max value="*" /> </element> <element id="Group.characteristic:race.code"> <path value="Group.characteristic.code" /> <patternCodeableConcept> <coding> <system value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type" /> <code value="race" /> </coding> </patternCodeableConcept> </element> <element id="Group.characteristic:race.value[x]"> <path value="Group.characteristic.value[x]" /> <type> <code value="CodeableConcept" /> </type> <binding> <strength value="extensible" /> <valueSet value="http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/group-race-value" /> </binding> </element> <element id="Group.characteristic:lifestyle"> <path value="Group.characteristic" /> <sliceName value="lifestyle" /> <min value="0" /> <max value="*" /> </element> <element id="Group.characteristic:lifestyle.code"> <path value="Group.characteristic.code" /> <patternCodeableConcept> <coding> <system value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type" /> <code value="lifestyle" /> </coding> </patternCodeableConcept> </element> <element id="Group.characteristic:lifestyle.value[x]"> <path value="Group.characteristic.value[x]" /> <type> <code value="CodeableConcept" /> </type> <binding> <strength value="extensible" /> <valueSet value="http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/group-lifestyle-value" /> </binding> </element> <element id="Group.characteristic:renalFunction"> <path value="Group.characteristic" /> <sliceName value="renalFunction" /> <short value="Renal function, typically a creatinine-clearance range in mL/min." /> <min value="0" /> <max value="1" /> </element> <element id="Group.characteristic:renalFunction.code"> <path value="Group.characteristic.code" /> <patternCodeableConcept> <coding> <system value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type" /> <code value="renal-function" /> </coding> </patternCodeableConcept> </element> <element id="Group.characteristic:renalFunction.value[x]"> <path value="Group.characteristic.value[x]" /> <type> <code value="Range" /> </type> </element> <element id="Group.characteristic:hepaticFunction"> <path value="Group.characteristic" /> <sliceName value="hepaticFunction" /> <min value="0" /> <max value="1" /> </element> <element id="Group.characteristic:hepaticFunction.code"> <path value="Group.characteristic.code" /> <patternCodeableConcept> <coding> <system value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type" /> <code value="hepatic-function" /> </coding> </patternCodeableConcept> </element> <element id="Group.characteristic:hepaticFunction.value[x]"> <path value="Group.characteristic.value[x]" /> <type> <code value="CodeableConcept" /> </type> <binding> <strength value="extensible" /> <valueSet value="http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/group-hepatic-function-value" /> </binding> </element> <element id="Group.characteristic:immuneStatus"> <path value="Group.characteristic" /> <sliceName value="immuneStatus" /> <min value="0" /> <max value="*" /> </element> <element id="Group.characteristic:immuneStatus.code"> <path value="Group.characteristic.code" /> <patternCodeableConcept> <coding> <system value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type" /> <code value="immune-status" /> </coding> </patternCodeableConcept> </element> <element id="Group.characteristic:immuneStatus.value[x]"> <path value="Group.characteristic.value[x]" /> <type> <code value="CodeableConcept" /> </type> <binding> <strength value="extensible" /> <valueSet value="http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/group-immune-status-value" /> </binding> </element> </differential> </StructureDefinition>